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Class 2 Device Recall |
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Date Initiated by Firm |
October 15, 2021 |
Create Date |
December 29, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0442-2022 |
Recall Event ID |
88998 |
510(K)Number |
K201945
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Product Classification |
Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
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Product |
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description:
39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS);
39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM);
39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS);
39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM);
39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE);
39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM);
39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES);
39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS);
39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS);
39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM);
39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES);
39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE);
39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES);
39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE);
39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE);
39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE);
39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM);
39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES);
39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES);
39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)
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Code Information |
All lots with Instructions for Use Prior to PI-000078-10.0 (06/21) |
Recalling Firm/ Manufacturer |
Karl Storz Endoscopy 2151 E Grand Ave El Segundo CA 90245-5017
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For Additional Information Contact |
424-218-8201
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Manufacturer Reason for Recall |
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
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FDA Determined Cause 2 |
Device Design |
Action |
On 10/15/21 correction notices were mailed to customers. Customers were asked to do the following: 1) Ensure all personnel in your organization review this letter and the current instructions for use. If you have previously sold or transferred affected devices to a third party, please forward this notice to all such third parties. 2) Discard any prior versions of the instructions for use. 3) Complete and return the acknowledgment form. Customers with medical or safety-related inquiries can contact Medical Affairs at 1-800-649-8852 or medicalaffairs@karlstorz.com. Customers with questions about the correction communication are encouraged to call 1-866-913-0667 or email karlstorz7824@stericycle.com. |
Quantity in Commerce |
71892 |
Distribution |
US: AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
OUS: Canada, Venezuela, Barbados, GUAM, Puerto Rico, Mexico, Northern Mariana Islands, Trinidad & Tobago, Germany, Cayman Islands, Philippines, Japan, Dominican Republic, Panama, Bahamas, Ecuador, Suriname, American Virgin Islands, British Virgin Islands, Belize, Curacao, The Bahamas, Brazil, South Korea, Bermuda
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = KCT and Original Applicant = Karl Storz EndoscopyAmerica Inc
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